The U.S. Food and Drug Administration recently announced that new "boxed warning" labels will be added to devices called laparoscopic power morcellators, which are used to grind up uterine fibroid growths.
The warning labels follow a recommendation issued in July by an FDA advisory panel that stated there's no way to guarantee surgical morcellation wouldn't increase the risk of spreading cancer to other parts of a woman's body.
Two other warnings will state that the morcellators should not be used in patients who are in or around menopause or in most patients who would need to undergo hysterectomy due to fibroids. The morcellators are also not to be used "in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous," the FDA added.
That's because in about one in every 350 cases, women who undergo hysterectomy for fibroids may have an unsuspected uterine sarcoma, the FDA said, and morcellation might help spread that cancer.
Read more here.
SOURCES: Nov. 24, 2014, news release, U.S. Food and Drug Administration; April 17, 2014, U.S. Food and Drug Administration news briefing with William Maisel, M.D., M.P.H., deputy director, science, and chief scientist, Center for Devices and Radiological Health; Wall Street Journal
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